Australia-based Noxopharm has completed enrolment of patients for Part 2 of the Phase I NOXCOVID trial of Veyonda to inhibit the cytokine release syndrome (CRS) and improve outcomes in hospitalised Covid-19 patients.
Part 2 of the trial is based on the positive data from Part 1, which showed that the 1,800mg dose of the drug was well tolerated by participants with compromised lung function.
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Blood samples from trial participants are being assessed at a laboratory in Australia to identify CRS and Covid-19 severity biomarkers.
At the end of the trial, the complete blood biomarkers analysis will be combined with the clinical results, including clinical status and co-morbidities. These data will then be reported to the market.
Veyonda is said to primarily moderate the ceramide/sphingosine-1-phosphate balance and block the Stimulator of Interferon Genes (STING) signalling.
Action on the ceramide/sphingosine-1-phosphate balance is said to cause oncotoxic and immuno-oncology effects, while activity against STING signalling leads to an anti-inflammatory effect.
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By GlobalDataNoxopharm said in a statement: “Independent pre-clinical studies have confirmed that idronoxil (the active ingredient in Veyonda) blocks this excessive STING response in what appears to be a comprehensive way, raising the prospect of successfully dampening down CRS in at-risk patients, and importantly, potentially blocking the release into the blood of multiple pro-inflammatory factors leading to blood clotting and major organ failure.”
NOXCOVID is being carried out in hospitals across Eastern European countries. The dose-escalation part of the trial included cohorts of 400mg, 600mg, 800mg, 1,200mg and 1,800mg Veyonda daily doses and the dose-expansion phase involved 1,800mg dose.
The objective of the trial is safety and biomarker and clinical responses, Noxopharm noted. It is designed to enrol about 40 Covid-19 patients hospitalised due to respiratory insufficiency.
